Recruiting

Fuzzy Wale Compression Stockinett

Sponsor:

Mayo Clinic

Code:

NCT06308562

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fuzzy Wale Compression Stockinet

Study Details

Brief summary:

The objective of this study is to determine if using Fuzzy Wale compression stockinet can assist in reducing the healing time and decrease costs in transtibial amputation patients as compared to standard of care treatment compression stocking.

Conditions

Peripheral Arterial Disease

Study ID

NCT06308562

Start date

Jul 7, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • >18 years
  • Male and female
  • Transtibial amputation expected.
  • Peripheral arterial disease and Transcutaneous partial pressure of oxygen (TCP02, if performed)
  • Ability of subject to give appropriate consent or have an appropriate representative available to do so.

Exclusion Criteria:

  • Known allergies to any of the components of the compression.
  • Terminal illness or current cancer therapy with chemotherapy
  • Inability to undergo ongoing care in Rochester.
  • Lack of cognitive ability to follow instructions or monitor residual limb.
  • Vulnerable study population
  • Pregnancy

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Fuzzy Wale Compression Stockinet

Subjects with peripheral arterial disease requiring transtibial amputation will have Fuzzy Wale Compression Stockinet applied and utilized for 4-8 weeks post operatively or until prosthetic fitting and wound has achieved full durable healing.

no intervention: Standard of care

Subjects with peripheral arterial disease requiring transtibial amputation will receive standard of care treatment compression stockinet.

Interventions

Fuzzy Wale Compression Stockinet

EdemaWear is a tubular, circular knit elastic stockinet fabricated with elastic, vertically oriented fuzzy wales, with the compression provided by the elastic, horizontal oriented Lycra® spandex yarns knitted in between. The stockinet is applied from the foot to the popliteal crease, over the affected area. EdemaWear can be applied in direct contact with the skin or over a wound care dressing. Sizing is based on leg circumference. EdemaWear is indicated for edema management of various etiologies (lymphedema, chronic venous insufficiency, congestive heart failure), and optimizing wound healing. The stockinette is often combined with other boxed compression sets. The manufacturer's stated dosage of EdemaWear is 8-12mmHg when used alone.

Primary outcome measure

  • Surgical site infection [ Time Frame: 8 weeks post-operatively ]
  • Wound dehiscence [ Time Frame: 8 weeks post-operatively ]
  • Pain control [ Time Frame: 8 weeks post-operatively ]
  • Time to prosthetic fitting [ Time Frame: 8 weeks post-operatively ]

Central Contacts and Locations

Central contacts

Vascular Research Team

(507) 538-7425Melin.Matthew@mayo.edu

Matthew Melin, M.D.

(507) 266-6717Melin.Matthew@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Vascular Research Team

(507) 538-7425

Matthew Melin, M.D.

(507) 266-6717Melin.Matthew@mayo.edu

Principal Investigator:

Matthew Melin, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-14.